NCT03492320

Brief Summary

To evaluate the progression on patients suffering from end stage OA whilst being on the waiting list for TKR

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2013

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed
Last Updated

April 10, 2018

Status Verified

April 1, 2018

Enrollment Period

3.8 years

First QC Date

April 3, 2018

Last Update Submit

April 3, 2018

Conditions

Keywords

HRQoLQuality of LifeEnd Stage OsteoarthritisTotal Knee ArthroplastyWOMACSF 36Total Knee Replacement

Outcome Measures

Primary Outcomes (3)

  • Western Ontario and McMaster University Osteoarthritis Index (WOMAC)

    Questionnaire

    From March 2013 to December 2016

  • Self-Rated Questionnaire SF36

    Questionnaire

    From March 2013 to December 2016

  • Health Related Quality of Life (HRQoL) 15D

    Questionnaire

    From March 2013 to December 2016

Interventions

Western Ontario and McMaster University Osteoarthritis Index (WOMAC), Self-Rated Questionnaire SF36 and Health Related Quality of Life (HRQoL) 15D questionnaire were used as outcome measurement for functionality and disability assessment.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study aims to evaluate the progression on patients suffering from end stage OA whilst being on the waiting list for TKR. This was a prospective longitudinal study, involving patients with symptomatic osteoarthritis at Prince of Wales Hospital Hong Kong. This study was conducted from March 2013 to December 2016. By universal sampling, patients who had experienced symptomatic OA visiting the Li Ka Shing Orthopaedic Specialist out-patient clinic were screened by a research nurse or a research assistant based on the inclusion criteria.

You may qualify if:

  • diagnosed with symptomatic osteoarthritis
  • Enlisted on the TKA surgical waiting list
  • Ethnic Chinese
  • Fluent in Cantonese

You may not qualify if:

  • Evidence of cognitive dysfunction like dementia
  • Surgery scheduled within 30 days
  • Severe co-morbidity preluding participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Ki Wai Ki Wai, Dr.

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor, Department of Orthopaedics & Traumatology; Director of MSc/PgD Programme in Musculoskeletal Medicine & Rehabilitation

Study Record Dates

First Submitted

April 3, 2018

First Posted

April 10, 2018

Study Start

March 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 10, 2018

Record last verified: 2018-04